PBAC's latest decision on Nalmefene: Not recommended (2015). Considered for Treatment of alcohol use disorder in patients with an average daily alcohol consumption of >60g for men and >40g for women, who have failed psychosocial intervention for at least 2 weeks, with the goal of reduction in alcohol consumption.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adults aged ≥18 years with alcohol use disorder (DSM-V) with an average daily alcohol consumption of >60g for men and >40g for women, who have failed to achieve adequate response to psychosocial intervention for at least 2 weeks, without physical withdrawal syndrome, not requiring immediate detoxification, and able to undergo concurrent psychosocial intervention.
Therapy area
Mental health
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Change from baseline in total alcohol consumption and number of heavy drinking days per month
ICER values are redacted (shown as '****' in the document). The submission presented a cost-utility analysis versus placebo and a cost-minimisation analysis versus naltrexone, but the specific ICER figures are commercially sensitive.
Why PBAC said no
Reasons cited in the latest PSD: uncertain clinical relevance of efficacy, inappropriate comparator weighting (one-third assumption not justified), concerns about trial population not reflective of PBS population (excluded mental health comorbidities), questions about non-inferiority to naltrexone, uncertain cost-minimisation assumptions